Cleared Special

SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70

K051010 · Septodont · Dental
May 2005
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K051010 is an FDA 510(k) clearance for the SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70, a Alloy, Amalgam (Class II — Special Controls, product code EJJ), submitted by Septodont (Washington, US). The FDA issued a Cleared decision on May 2, 2005, 11 days after receiving the submission on April 21, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3070.

Submission Details

510(k) Number K051010 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2005
Decision Date May 02, 2005
Days to Decision 11 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJJ — Alloy, Amalgam
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3070